Pfizer’s Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, Adsorbed]) has been launched in the UK for active immunisation of invasive disease caused by Streptococcus pneumoniae in adults aged 50 and over.

It becomes the first and only pneumococcal conjugate vaccine to be licensed for adults aged 50 and over after gaining a new indication from the EMA.

Dr George Kassianos, GP and immunisation lead for the Royal College of GPs and the British Travel Health Association, says its introduction is an “important achievement and step forward” for adult patients.

The vaccine was first licensed for infants and young children in December 2009 in Europe and used during the UK’s Childhood Immunisation Schedule in April last year.

The new indication provides a new treatment option for the prevention of adult invasive pneumococcal disease (IPD), which includes the potentially fatal bacteraemic pneumonia, meningitis and septicaemia.

Chris Head, CEO of the Meningitis Research Foundation, welcomed the vaccine’s launch in the UK. “The new license for Prevenar 13 provides an opportunity to protect adults over 50, who are more at risk of serious pneumococcal disease than younger adults,” he said.

Until Prevenar 13’s new indication, adults over 65 and those in clinical risk groups were treated with the pneumococcal polysaccharide vaccine. But in clinical trials, patients given Prevenar 13 had significantly higher antibody responses with the vaccine expected to protect against seven out of the most ten most comment serotypes which causes IPD.

Eli Lilly has won its first trial over health risks concerning its anti-psychotic drug, Zyprexa.

It is the first of 40 outstanding patient lawsuits involving the medication that claim the company concealed the drug’s side effects from patients and doctors.

Approximately 31,000 patient lawsuits were originally filed, most of which were covered by a $1.2 billion settlement, leaving 110 patient claims pending in 40 lawsuits.

The case in Los Angeles was filed by the family of a 20-year-old student who died while taking Zyprexa. They said that Lilly hid the medicine’s safety risks whilst marketing the medication for both approved and off-label uses in the US.

The lawsuit also claimed that the pharmaceutical company trained its sales representatives to counteract questions regarding risks of weight gain and diabetes linked to Zyprexa.

In addition to its settlement deal of $1.2 billion, Lilly also paid $1.42 billion for federal off-label marketing investigations and $260 million for state claims.

The EC has approved Eli Lilly’s Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC).

Alimta is the first chemotherapy to be approved in Europe for continuation maintenance therapy, for NSCLC patients who have shown a positive response or disease stabilisation following treatment with first-line Alimta plus cisplatin.

Allen Melemed, Senior Medical Director at Lilly Oncology, said: “Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient.”

The European approval was based on results from PARAMOUNT, a randomised double-blind Phase III study of 939 patients with advanced nonsquamous NSCLC.

The study showed that Alimta continuation maintenance therapy improved progression-free survival, as well as overall survival, after Alimta-cisplatin first-line therapy.

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

The drug is also approved for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma in the EU and US.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths every year. Approximately 85-90% of all lung cancers are NSCLC.

Alimta was recommended by CHMP as continuation maintenance therapy for patients with advanced nonsquamous NSCLC in September 2011 and by NICE for use by the NHS in September 2009.

Pfizer has agreed to pay $14.5 million for illegally marketing overactive bladder drug Detrol, for males with benign prostatic hypertrophy.

The settlement resolves the last of ten whistleblower suits that were filed by the government against Pfizer, under which the company agreed to pay $2.3 billion dollars to resolve multiple civil claims and criminal charges.

Carmen Ortiz, US Attorney for the District of Massachusetts, said: “We hope and expect that this is indicative of a commitment to move forward in compliance with the law, and we will continue to watch vigilantly to ensure that Pfizer complies with the law in its sales and marketing of drugs sold to the public.”

It was filed that the company illegally marketed Detrol for treatments not approved by the FDA, marketing it for use in men suffering from benign prostatic hypertrophy and several allied conditions, including lower urinary tract symptoms and bladder outlet obstruction.

Tony West, Assistant Attorney General of the Justice Department's Civil Division, said: “Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse.”

The $14.5 million fine will be divided between the US and participating state Medicaid programs, with nearly $12 million going to the federal government and $2.5 million going to state Medicaid programmes.

“Settlements like this one help maintain the integrity of FDA's drug approval process and support important federal and state health care programs,” added Mr West.

This settlement is part of the government scheme to combat healthcare fraud through the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was established in May 2009.

Novartis will cut 2,000 manufacturing jobs in Switzerland and the US – despite seeing an increase in group net sales and operating income in Q3.

The positions will be cut by 2016 after the closure of two Swiss production sites and one in Italy, plus the restructuring and relocation of R&D activities from Switzerland to the US.

Joseph Jimenez, CEO of Novartis, said the job losses are needed for the Group to “continue delivering on our mission of bringing innovative new drugs to patients.”

However, the job losses will be offset by the creation of 700 new positions in low cost and other countries, the company said.

The Group recorded a sales increase of 12% in constant currencies to $14.8 billion and saw income also grow by 11% to $4.1bn.

Sales were boosted by a strong performance from recently launched products – which contributed 25% of net sales.

Pharmaceutical sales grew 9% after Afinitor (pictured)/Votubia was approved in the EU for two additional indications, the CHMP granted a positive opinion for Rasitrio for high blood pressure and the company’s breakthrough multiple sclerosis treatment, Gilenya, won approval in Japan.

“Once again, the breadth of our business and product portfolio allowed us to deliver strong financial results and operating leverage, as well as significantly advancing the pipeline in the quarter,” said Mr Jimenez. “To strengthen our future, we have accelerated actions to reduce our cost base over the next few years.”

A number of regional NHS authorities in England are approving the use of Avastin (pictured) instead of Lucentis for ophthalmology patients.

Unlicensed Avastin (bevacizumab) is similar to EU-approved Lucentis (ranibizumab), but is now frequently preferred as a treatment of age-related macular degeneration (AMD) to Lucentis due to its lower cost.

The Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT cluster says the change in treatment could save the local health service £5 million a year.

Dr Stuart Ward, Medical Director for SHIP PCT Cluster, said: “The policy approved by the Board simply gives consultants authority to offer their patients the choice of Avastin which, until now, has not been routinely available on the NHS. Patients will be given clear information about the effectiveness and safety of the alternative drug and will be able to discuss this with their consultant before making their choice.”

The PCT Cluster says the initial feedback from local patients who have using Avastin has been positive, with the majority saying their vision had improved or stabilised.

The North East Treatment Advisory Group in the north of England estimated a potential saving of £4 million a year if all AMD patients were treated with Avastin rather than Lucentis.

The Cluster is now working with local providers of AMD treatment to implement the new policy.

In response to the rise in patients choosing Avastin over Lucentis, Novartis UK are understood to be considering reducing the price of Lucentis.

Tim Cave, Medical Director for the company in the UK, said: “We’re worried that in looking at efficiency people are throwing out the principle of keeping patients safe.”

A US government study in May showed that Avastin was as effective at treating AMD as Lucentis. The trial compared Lucentis against the off-label use of Avastin and found it had comparable efficacy in improving vision compared to Novartis’ AMD product, and is also available at fraction of the price.

Roche’s Avastin is licensed in the EU as a treatment for metastatic breast cancer in combination with paclitaxel.

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.